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510(k) K161610

EXPRT Revision Hip System by Encore Medical, L.P. — Product Code KWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2016
Date Received
June 10, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3310
Review Panel
OR
Submission Type

Other clearances by Encore Medical, L.P.

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  • K241483 — ceramys™ femoral head system (February 7, 2025)
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Other clearances for product code KWZ

  • K241461 — Mpact Constrained Liner (July 31, 2025)
  • K240639 — PINNACLETM Constrained Acetabular Liners (April 4, 2024)
  • K162641 — Smith & Nephew, Inc. R3™ Constrained Liner (June 19, 2017)
  • K163497 — EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset (March 2, 2017)
  • K122139 — SMITH & NEPHEW R3 CONSTRAINED LINERS (October 16, 2012)
  • K111635 — SMITH & NEPHEW RJ CONSTRAINED LINERS (September 9, 2011)
  • K101730 — LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS (December 3, 2010)
  • K083566 — R3 CONSTRAINED LINER, CONSTRAINED LINER (March 3, 2009)
  • K072121 — TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER (January 7, 2008)
  • K071059 — DEPUY SPA POROUS COATED PROXIMAL SLEEVE (November 9, 2007)